(171 days)
Heat and passive humidification with filtration between patient and circuit. Designed for use with all ISO compliant airway management systems including ventilators, respirators, and open flow systems where filtration of inspired or expired gases is required such as in hospitals, surgical centers, long term healthcare facilities and the home utilizing anesthesiology or respiratory equipment. Place at anytime on the inspiratory and/or expiratory side of the patient circuit. For single patient use only. For sale by or on the order of a physician.
The Series 1 Breathing Circuit Filter is a filter device intended to remove microbiological and particulate matter from the gases in a breathing circuit similar to the SIMS Portex, Inc. Breathing Filter and Filtered HME. The Series 1 Breathing Circuit Filter features include the following: Hydrophobic filter media, Hydrophilic filter media, Sonic welded housing, ISO compliant.
The provided text is a 510(k) Summary for the "Series 1 Breathing Circuit Filter." It describes the device, its intended use, and claims substantial equivalence to another marketed device. However, it does not contain the detailed information necessary to complete a table of acceptance criteria, reported device performance, or details of a study proving the device meets those criteria as requested in your prompt.
Specifically, the document states:
- "Substantial equivalence is based on independent laboratory testing performed at Nelson Laboratories and the University of Cincinnati. The Series 1 Breathing Circuit Filter met all standards for filtration and humidity control consistent with industry standards."
- "Clinical Data: Not available."
This means:
- There's no explicit table of acceptance criteria within this document. The criteria are only broadly referred to as "standards for filtration and humidity control consistent with industry standards."
- There are no specific performance metrics provided (e.g., filtration efficiency percentages, pressure drop values).
- No details about the "independent laboratory testing" are given (e.g., sample size, ground truth, expert involvement).
- There was no clinical study, which would typically involve human subjects or human readers (MRMC, standalone).
Therefore, I cannot provide a complete answer to your request based on the provided text.
To illustrate what a potential answer would look like if the information were available, here's a template, but the fields will be marked as "Not provided in the text" for this specific document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Filtration (Bacterial) | Not provided in the text | "Met all standards" (details not provided) |
| Filtration (Viral) | Not provided in the text | "Met all standards" (details not provided) |
| Humidity Control | Not provided in the text | "Met all standards" (details not provided) |
| Pressure Drop | Not provided in the text | Not provided in the text |
| Biocompatibility | Not provided in the text | Not provided in the text |
2. Sample size used for the test set and the data provenance
Not provided in the text. The document refers to "independent laboratory testing" but does not specify sample sizes or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not provided in the text. The testing was laboratory-based, and human expert consensus on ground truth is not applicable for this type of performance testing on a breathing filter.
4. Adjudication method for the test set
Not applicable. The testing was laboratory-based performance testing of a physical device, not an assessment requiring human adjudication of results in the traditional sense (e.g., medical image interpretation).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a physical breathing circuit filter, not an AI diagnostic tool. No human reader study was conducted, and the document explicitly states "Clinical Data: Not available."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical breathing circuit filter, not an algorithm. Performance testing was done on the physical product in a laboratory setting.
7. The type of ground truth used
For the laboratory testing, the ground truth would have been established by standardized laboratory methods and measurements for filtration efficiency and humidity output, not expert consensus, pathology, or outcomes data. Specifics of these ground truth methods are "Not provided in the text."
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML algorithm. Therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a physical breathing filter.
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).